Hammerli 208 International Manual Of Planning

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Major depressive disorder (MDD) is one of the most prevalent psychiatric disorders, with a lifetime prevalence that is currently estimated at about 16% [1, 2, 3] and predicted to further increase in the foreseeable future [4, 5]. By 2030, depressive disorders are anticipated to be responsible for the highest disease burden in high-income countries among all diseases [6]. Suffering from MDD is accompanied by a substantial loss in quality of life, not only for patients but also for their relatives [7, 8, 9]. Furthermore, suffering from a depressive episode is associated with a high risk of relapse and recurrence [1, 10] as well as a chronic course [11], increased mortality rates [12], significant disability, high medical service use, and major economic costs [13, 14, 15, 16].

Although numerous studies provide evidence for the efficacy of available psychological and pharmacological treatments [17, 18], many individuals remain untreated [19, 20]. The reasons for this treatment gap are twofold. First, individuals who likely to benefit from treatment do not seek treatment because they lack knowledge on available treatment options, anticipate negative (social) consequences, live in underserved areas, fear prohibitive costs, or prefer self-help [20]. Limited availability of clinicians and difficulties in attending therapy during usual business hours are further barriers [21]. Second, those who do seek help rarely receive immediate access to treatment due to long waiting lists for both inpatient and outpatient psychotherapy [20, 22]. Consequently, people with an urgent need for therapy are left alone with their burden, which poses several ethical, practical, and therapeutic problems. In addition to high levels of suffering, long waiting times might increase symptom severity and hence increase the need for more intense and longer treatments [23, 24].

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Another related problem is that because of factors such as limited financial resources and time, inpatient patients are often discharged from the clinic at a very early stage, leaving them with substantial residual symptoms. However, even low levels of residual symptoms are known to increase the risk for relapse and recurrence [25, 26, 27, 28]. Recent meta-analyses show that between 40 and 60% of patients with MDD relapse after the initial response to an acute-phase treatment [27].

The use of the internet to provide guided self-help might contribute to solving these problems. First, meta-analytical evidence has shown comparable effects of such interventions compared to traditional psychological treatments when there is at least some support from a professional [29, 30, 31]. Furthermore, web-based interventions may represent a far-reaching method for supporting patients during the waiting time for psychotherapy [32].

This method has been well accepted by patients and shown to be effective in the acute treatment phase as well as the maintenance phase [33, 34, 35, 36, 37]. The adaptation of internet-based strategies for the waiting phase has several advantages: (a) patients can begin their treatment immediately with no additional waiting time; (b) the online program can be used 24 hours a day, independent of office hours, every day of the week; (c) the material can be reviewed as often as needed; (d) the patient can use it in a familiar environment, without any time or travel costs, which allows for privacy and consistency of care [34, 38, 39]; and (e) web-based interventions can help patients to practise skills that are relevant for their subsequent therapy (i.e., self-monitoring, problem-solving competencies, behavioural activation).

Hammerli 208 International Manual Of Planning

However, to the best of our knowledge, only one study has evaluated the use of internet-based guided self-help for patients on a waitlist for psychotherapy [40]. In this non-randomised observational study, the researchers found large and significant between-group effect sizes for online treatment for depression (d = 0.94) compared to a waiting control group after five weeks. The majority of eligible patients preferred the web-based problem-solving therapy instead of waiting for face-to-face treatment. Participation in this intervention increased the speed of improvement for symptoms of depression during the following therapy [40].

Hammerli 208 International Manual Of Planning

Given the high level of suffering from a depressive episode and the limited availability of psychotherapy resources, new and innovative approaches are needed to address the long waiting times. Using waiting times effectively by providing patients with evidence-based guided self-help methods might result in higher remission rates at the end of inpatient treatment or an earlier remission, thereby reducing costs.

Hammerli 208 International Manual Of Planning Manual

Trial objectives and purpose

Hammerli 208 International Manual Of Planning System

The aim of this multi-centre randomised controlled trial is to evaluate whether a newly developed web-based guided self-help intervention (GET.ON-Mood Enhancer-WL) is effective in reducing depressive symptom severity in patients waiting for inpatient therapy when compared to treatment-as-usual. Moreover, it will be explored whether participants would respond or achieve remission earlier in the course of the subsequent inpatient therapy and would be more likely to be fully remitted at discharge than would controls.